PeriodontitisPhase 1/2NCT05107622
Administration of L. Paracasei 28.4 as an Adjunct to the Treatment of Periodontitis
A Phase 1/2 study testing FMUD+Probiotic in people with Periodontitis, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
Trial summary
The aim of this study is to evaluate the effects of probiotic administration of L. paracasei 28.4 as an adjunct to the non-surgical periodontal treatment in patients with periodontitis. Read more about this study
- Who is it for?
- Ages 35 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- FMUD+Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 16 Aug 2021to Apr 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of stage III/IV and grade B/C generalized periodontitis;
- Presence of at least 20 teeth in the mouth;
- Signing the informed consent form.
Who cannot join
- Presence of systemic conditions that contraindicate the periodontal procedure or influence the progression of the disease;
- Periodontal treatment history in the last six months;
- Use of antibiotics or probiotics in the last six months;
- Smoke more than 10 cigarettes a day;
- Pregnant or breastfeeding;
- Chronic use of anti-inflammatory drugs or medications that can alter the response of periodontal tissues;
- Need of antibiotic prophylaxis for dental procedures;
- Need of probiotic therapy.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Mauro Pedrine Santamaria
São José dos Campos, São Paulo, 12245000
Laís FF Ferraz, MS, (15) 991756747 ext. +55, lais.ferraz@hotmail.com
About this study
Official title: Administration of L. Paracasei 28.4 as an Adjunct to the Treatment of Periodontitis: Superiority Placebo-controlled Randomized Clinical Trial
The aim of this study is to evaluate the effects of probiotic administration of L. paracasei 28.4 as an adjunct to the non-surgical periodontal treatment in patients with periodontitis.
Read the detailed description
This is a superiority placebo-controlled randomized clinical trial. The population that will be evaluated in the study will be selected at Institute of Science and Technology (ICT), São José dos Campos, College of Dentistry.
Sixty patients presenting Stage III/IV and Grade B/C periodontitis will be divided into 2 groups:
- FMUD+Placebo (n=30): full-mouth ultrasonic periodontal debridement associated with administration of placebo formulation, twice a day for 30 days;
- FMUD+Probiotic (n=30): full-mouth ultrasonic periodontal debridement associated with administration of probiotic formulation twice a day for 30 days.
The study will consist of two stages of treatment:
- Initial therapy: Before starting treatment, a complete examination of the oral cavity and evaluation of periodontal parameters will be performed. All patients will undergo a prior adjustment of the oral environment and oral hygiene. Thirty days after completion of initial therapy, a new periodontal evaluation will be performed and only patients who present a visible plaque index less than or equal to 25% will undergo subgingival periodontal debridement.
- Non-surgical periodontal therapy: After initial therapy, all patients will receive full-mouth ultrasonic periodontal debridement. Debridement will be performed by a single operator, trained, blind to the allocation of patients and different from the evaluator. If there is any complication that prevents the completion of full-mouth debridement, the procedure will be finished within a maximum period of 24 hours. The randomization envelope will be opened and the probiotic/placebo formulation will be delivered to patients. They will be instructed to consume the samples twice a day during the 30 days following periodontal treatment.
All clinical measurements will be performed by a single researcher, previously calibrated for the measurements. After periodontal therapy, treatment results will be evaluated three and six months after periodontal debridement associated with the use of placebo/probiotic formulation. Indications of adverse oral effects will be verified by visual assessment at 7, 30 and 90 days after the start of consumption of formulations.
To assess patient-centered parameters, the OHIP-14 questionnaire will be applied before and after 6 months of periodontal treatment for each patient. A 30-days diary will be used to assess the adherence to use and occurrence adverse effects.
Microbiological and immunological analyzes will be carried out through subgingival biofilm and gingival crevicular fluid samples collected from sites with moderate pockets and sites with deep pockets at baseline, 3 and 6 months after therapy.
- Conditions
- Periodontitis
- Being tested
- FMUD+Probiotic, FMUD+Placebo
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FMUD+ProbioticOther
Full-mouth ultrasonic periodontal debridement associated with administration of probiotic formulation (Lactobacillus paracasei 28.4) twice a day for 30 days.
FMUD+PlaceboOther
Full-mouth ultrasonic periodontal debridement associated with administration of placebo formulation twice a day for 30 days.
| Study group | Role | What they receive |
|---|---|---|
| FMUD+Probiotic | Experimental | FMUD+Probiotic (n=30): full-mouth ultrasonic periodontal debridement associated with administration of probiotic formulation twice a day for 30 days. Receives: Other: FMUD+Probiotic |
| FMUD+Placebo | Placebo comparator | FMUD+Placebo (n=30): full-mouth ultrasonic periodontal debridement associated with administration of placebo formulation, twice a day for 30 days. Receives: Other: FMUD+Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of pockets with PD ≥ 5 mm
Number of pockets with probing depth ≥ 5 mm
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start16 Aug 2021
- Primary completionDec 2023 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mauro Pedrine Santamaria, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Laís F Ferraz, MS, Principal investigator, Sao Paulo State University - BrazilMauro P Santamaria, PhD, Study director, Sao Paulo State University - Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05107622
- Sponsor's protocol ID
- Lp + PD
- Status last verified
- Oct 2022
- First submitted
- 25 Oct 2021
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available at the end of the study after a direct request.
Publications
Ribeiro FC, Junqueira JC, Dos Santos JD, de Barros PP, Rossoni RD, Shukla S, Fuchs BB, Shukla A, Mylonakis E. Development of Probiotic Formulations for Oral Candidiasis Prevention: Gellan Gum as a Carrier To Deliver Lactobacillus paracasei 28.4. Antimicrob Agents Chemother. 2020 May 21;64(6):e02323-19. doi: 10.1128/AAC.02323-19. Print 2020 May 21.
PubMed 32253208Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.
PubMed 29926952Teughels W, Durukan A, Ozcelik O, Pauwels M, Quirynen M, Haytac MC. Clinical and microbiological effects of Lactobacillus reuteri probiotics in the treatment of chronic periodontitis: a randomized placebo-controlled study. J Clin Periodontol. 2013 Nov;40(11):1025-35. doi: 10.1111/jcpe.12155. Epub 2013 Sep 15.
PubMed 24164569
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of L. Paracasei 28.4 as an Adjunct to the Treatment of Periodontitis: Superiority Placebo-controlled Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05107622
- Acronym / sponsor ID
- Lp + PD
- Conditions
- Periodontitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 4 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the effects of probiotic administration of L. paracasei 28.4 as an adjunct to the non-surgical periodontal treatment in patients with periodontitis.
Detailed description
This is a superiority placebo-controlled randomized clinical trial. The population that will be evaluated in the study will be selected at Institute of Science and Technology (ICT), São José dos Campos, College of Dentistry.
Sixty patients presenting Stage III/IV and Grade B/C periodontitis will be divided into 2 groups:
- FMUD+Placebo (n=30): full-mouth ultrasonic periodontal debridement associated with administration of placebo formulation, twice a day for 30 days;
- FMUD+Probiotic (n=30): full-mouth ultrasonic periodontal debridement associated with administration of probiotic formulation twice a day for 30 days.
The study will consist of two stages of treatment:
- Initial therapy: Before starting treatment, a complete examination of the oral cavity and evaluation of periodontal parameters will be performed. All patients will undergo a prior adjustment of the oral environment and oral hygiene. Thirty days after completion of initial therapy, a new periodontal evaluation will be performed and only patients who present a visible plaque index less than or equal to 25% will undergo subgingival periodontal debridement.
- Non-surgical periodontal therapy: After initial therapy, all patients will receive full-mouth ultrasonic periodontal debridement. Debridement will be performed by a single operator, trained, blind to the allocation of patients and different from the evaluator. If there is any complication that prevents the completion of full-mouth debridement, the procedure will be finished within a maximum period of 24 hours. The randomization envelope will be opened and the probiotic/placebo formulation will be delivered to patients. They will be instructed to consume the samples twice a day during the 30 days following periodontal treatment.
All clinical measurements will be performed by a single researcher, previously calibrated for the measurements. After periodontal therapy, treatment results will be evaluated three and six months after periodontal debridement associated with the use of placebo/probiotic formulation. Indications of adverse oral effects will be verified by visual assessment at 7, 30 and 90 days after the start of consumption of formulations.
To assess patient-centered parameters, the OHIP-14 questionnaire will be applied before and after 6 months of periodontal treatment for each patient. A 30-days diary will be used to assess the adherence to use and occurrence adverse effects.
Microbiological and immunological analyzes will be carried out through subgingival biofilm and gingival crevicular fluid samples collected from sites with moderate pockets and sites with deep pockets at baseline, 3 and 6 months after therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FMUD+Probiotic | Experimental | Other: FMUD+ProbioticFMUD+Probiotic (n=30): full-mouth ultrasonic periodontal debridement associated with administration of probiotic formulation twice a day for 30 days. |
| FMUD+Placebo | Placebo comparator | Other: FMUD+PlaceboFMUD+Placebo (n=30): full-mouth ultrasonic periodontal debridement associated with administration of placebo formulation, twice a day for 30 days. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of stage III/IV and grade B/C generalized periodontitis;
- Presence of at least 20 teeth in the mouth;
- Signing the informed consent form.
Key exclusion criteria (8 listed)
- Presence of systemic conditions that contraindicate the periodontal procedure or influence the progression of the disease;
- Periodontal treatment history in the last six months;
- Use of antibiotics or probiotics in the last six months;
- Smoke more than 10 cigarettes a day;
- Pregnant or breastfeeding;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FMUD+ProbioticFull-mouth ultrasonic periodontal debridement associated with administration of probiotic formulation (Lactobacillus paracasei 28.4) twice a day for 30 days. | Other | FMUD+Probiotic |
| FMUD+PlaceboFull-mouth ultrasonic periodontal debridement associated with administration of placebo formulation twice a day for 30 days. | Other | FMUD+Placebo |
Primary outcome
Number of pockets with PD ≥ 5 mm
Time frame: 6 months
Number of pockets with probing depth ≥ 5 mm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Background: PubMed 32253208Ribeiro FC, Junqueira JC, Dos Santos JD, de Barros PP, Rossoni RD, Shukla S, Fuchs BB, Shukla A, Mylonakis E. Development of Probiotic Formulations for Oral Candidiasis Prevention: Gellan Gum as a Carrier To Deliver Lactobacillus paracasei 28.4. Antimicrob Agents Chemother. 2020 May 21;64(6):e02323-19. doi: 10.1128/AAC.02323-19. Print 2020 May 21.
- Background: PubMed 29926952Tonetti MS, Greenwell H, Kornman KS. Staging and grading of periodontitis: Framework and proposal of a new classification and case definition. J Periodontol. 2018 Jun;89 Suppl 1:S159-S172. doi: 10.1002/JPER.18-0006.
- Background: PubMed 24164569Teughels W, Durukan A, Ozcelik O, Pauwels M, Quirynen M, Haytac MC. Clinical and microbiological effects of Lactobacillus reuteri probiotics in the treatment of chronic periodontitis: a randomized placebo-controlled study. J Clin Periodontol. 2013 Nov;40(11):1025-35. doi: 10.1111/jcpe.12155. Epub 2013 Sep 15.
- Individual participant dataSharing planned: Yes. Data will be available at the end of the study after a direct request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laís F Ferraz, MS principal investigator
Sao Paulo State University - Brazil
Mauro P Santamaria, PhD study director
Sao Paulo State University - Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FMUD+Probiotic in people with Periodontitis, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mauro P Santamaria, PhD ((12) 39479055 ext. +55, mauro.santamaria@unesp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of pockets with PD ≥ 5 mm (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05107622, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2022.